The European Court affirms that public safety comes first: financial considerations cannot justify the placing on the market of unlicensed medicines

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Abstract:

On 29 March 2012, the European Court of Justice (CJEU) issued a ruling in a case brought by the European Commission against Poland declaring unlawful the supply of unlicensed medicines on financial grounds as a cost containment measure. The article looks into this judgment and assesses its significance in view of the increasing tendency of national healthcare authorities to look for new ways to reduce their costs. We give an overview of the regulatory framework for the authorisation of medicinal products and explain the limited possible derogations. The article then examines the main points of the ruling which declared that Poland has failed to fulfill its obligations under Article 6 of Directive 2001/83/EC on the Community code relating to medicinal products by adopting and maintaining in force Article 4 of its 2001 Law on Medicinal Products. The analysis will look at the Court’s interpretation of the scope of Article 5(1) of the Directive and the role of financial considerations thereunder. We explain why the judgment is consistent with established case law, which stresses the need to financial considerations from trumping the regulatory framework, with its focus on public health. Finally, the article notes the relevance of this judgment to the current controversy about some UK authorities’ decisions to encourage off-label use of Avastin for cost saving reasons. Clearly the judgment casts strong doubt on the legality of such UK authorities’ decisions.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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